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Study Summary
No. 2007-0339:.......Breast......Jose Banchs......Cardiology
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Study Summary Title
Study Summary
Number:		2007-0339
Study Title:Early Detection and Prediction of Chemotherapy Induced Cardiac Toxicity in Breast Cancer Patients
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Physician New Patient Referral
Name:Jose BanchsPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:CardiologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-794-4197
Contact us about clinical trials
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General Information
Disease Group:BreastSupported By:Claflin Distinguished Scholar Award, Massachusetts General Hospital
Phase of Study:N/AReturn
Visit:		6 visits - Baseline, then approximately every 3 months for 15 months
Treatment
Agents:		Advia Centaur immunoassay system
GE Vivid ultrasound machine
Roche 2010 system		Home Care:N/A
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		No hospitalization is required for this study
Description/
Intervention:		The goal of this clinical research study is to learn whether different ways of
viewing echocardiogram pictures along with blood tests can help to see
heart-related side effects of chemotherapy and trastuzumab earlier than the
usual tests.
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Study Objectives / Outcomes
The primary objectives of this study are:

1. To determine whether tissue Doppler imaging and/or circulating levels of B-type natriuretic peptide, or its byproduct aminoterminal pro-B-type natriuretic peptide, and ultrasensitive troponin are early and sensitive markers of cardiac toxicity in breast cancer patients treated with trastuzumab (Herceptin). We hypothesize that early abnormalities of tissue Doppler imaging and/or natriuretic peptides or troponin will predict a later decrease in left ventricular function.

2. To test whether metabolic profiling can predict or detect in an early manner treatment-induced cardiac toxicity in breast cancer patients.

3. To determine whether common HER-2 single nucleotide polymorphisms identify a subgroup of breast cancer patients at high risk developing cardiac toxicity with Herceptin therapy.

4. To determine whether Herceptin infusion causes acute changes in cardiac function.
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Study Status Information
Study Activation / Registration Date:11/12/2008
IRB Review and Approval Date:09/06/2007
Study Type:Other
Recruitment Status:Terminated
Projected Accrual:100
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Age 18 years or older

2) HER-2 positive breast cancer

3) Scheduled to receive Herceptin infusion therapy after exposure to anthracycline-based chemotherapy in one of the following manners: Adjuvant or neoadjuvant treatment with antracycline-based chemotherapy preceded or followed by Herceptin infusion therapy, Herceptin monotherapy in patients with metastatic disease previously treated with anthracycline-based chemotherapy, Herceptin in combination with non-anthracycline chemotherapy in patients with metastatic disease previously treated with anthracycline-based chemotherapy.

4) Normal baseline left ventricular ejection fraction
Exclusion Criteria:1) Pre-existing cardiomyopathy (LVEF < 50%)

2) Other contraindication to Herceptin therapy
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Links
Registration Number: NCT00806507
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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